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Muscle Function Assessment for Postpartum Women

N/A

Recruiting

Led By Rita Deering, PT, DPT, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Prescription anti-inflammatory/pain medications that are taken daily

Neuromuscular health conditions (such as diabetes, neuropathy, multiple sclerosis, stroke, seizures, etc)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will measure muscle function and activity levels in women who have never been pregnant and those who have given birth. It aims to understand how well their muscles control force and how quickly they get tired during exercises. The study will help identify factors affecting muscle performance in daily activities.

Who is the study for?

This trial is for women who have recently given birth to their first child and are experiencing muscle weakness or fatigue. They should not be on daily anti-inflammatory/pain medications, have significant orthopedic conditions, previous abdominal surgeries (except Cesarean), or any neuromuscular health issues.

What is being tested?

The study will use ultrasound imaging and various physical tests to assess the muscle function of the lower body and abdomen in new mothers. Participants will attend two sessions about a week apart to measure their neuromuscular control.

What are the potential side effects?

There may be minimal side effects from this study as it involves non-invasive testing such as ultrasound imaging and physical strength assessments. However, some discomfort during testing due to exertion might occur.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take prescription anti-inflammatory or pain medication daily.

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I have a condition affecting my nerves or muscles, like diabetes or MS.

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I do not have severe bone conditions that would prevent me from performing physical tasks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Abdominal Fascial Integrity Measured by Mean Inter-Recti Distance

Incidence of Lumbopelvic Instability

Incidence of Perceived Difficulty with ASLR Task

+5 more

Secondary study objectives

Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score

Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Ratings of Perceived Exertion (RPE)

Average Minutes per Day of Activity in at least 10-minute bouts

+15 more

Other study objectives

Mean discharge rate of single motor units

Percent of Maximum Voluntary Isometric Contraction (MVIC)

Root mean square (RMS) of global EMG

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PostpartumExperimental Treatment4 Interventions

Participants who are six months postpartum will complete 2 experimental sessions, separated by 7-10 days. Participants will complete multiple questionnaires, maximal voluntary contractions of the lower extremity muscles, clinical tests of lumbopelvic neuromuscular control/posterior pelvic pain provocation, and fatiguing lower extremity/trunk muscle exercise. Ultrasound imaging will be performed to measure inter-recti distance. Wireless Electromyography (EMG) sensors will be used to record EMG and limb steadiness (via Inertial Measurement Units (IMU). Physical activity will be measured by questionnaire and accelerometer.

Group II: NulligravidActive Control4 Interventions

Participants who have never been pregnant will complete 2 experimental sessions, separated by 7-10 days. Participants will complete multiple questionnaires, maximal voluntary contractions of the lower extremity muscles, clinical tests of lumbopelvic neuromuscular control/posterior pelvic pain provocation, and fatiguing lower extremity/trunk muscle exercise. Ultrasound imaging will be performed to measure inter-recti distance. Wireless EMG sensors will be used to record EMG and limb steadiness (via IMUs). Physical activity will be measured by questionnaire and accelerometer.

0 / 3Eligibility criteria met